Events

Retiro De Equipo (Recall) de Oxoid Antimicrobial Susceptibility Testing Discs for Gentamicin (CN10). An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Thermo Fisher Scientific Australia & New Zealand.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00173-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00173-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Investigations have confirmed that cartridges within this batch may contain individual discs that are not impregnated with antibiotic. this could lead to a false indication of resistance to gentamicin.
  • Acción
    Thermo Fisher Scientific is requesting customers to inspect stock and remove any affected units from further use. A credit note will be issued once affected stock has been confirmed. This action has been closed-out on 12/02/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Discs for Gentamicin (CN10). An in vitro diagnostic me...

Manufacturer

Thermo Fisher Scientific Australia & New Zealand